MAUDE Adverse Event Report: STRYKER GMBH NAIL HOLDING SCREW GAMMA4; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	14200105
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the gamma4 device and the nail are no longer disconnected".
Additional Manufacturer Narrative
Correction: please refer to g1 reporting contact, h6 device code.The reported event could be confirmed, since the device was returned for evaluation, and it was found stuck with other devices.The nail, nail holding screw and the proximal targeting arm was received in stuck condition.All the devices were separated out from each other by applying some excess amount of force.After disassembly, external threads of the nail holding screw found slightly worn out most probably due to application of excess torsional force while tightening the nail holding screw and the nail.First, all the three stuck devices were separated out from each other and after that they were assembled again using reasonable amount of tightening force and it was observed that they can be easily assembled and disassembled again and again without any issue.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation, the root cause was attributed to a usage related issue.The event was caused due to application of excess forces while tightening the nail with the nail holding screw due to which all three components got temporarily stuck with each other.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the gamma4 device and the nail are no longer disconnected".

• Brand Name: NAIL HOLDING SCREW GAMMA4
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21354833
• Report Number: 0008031020-2025-00260
• Device Sequence Number: 9003080
• Product Code: HSB
• UDI-Device Identifier: 07613327479928
• UDI-Public: 07613327479928
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 14200105
• Device Lot Number: KP506404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown